SUNBEAM
Received Dec 12, 2024 · Event occurred Dec 2, 2023
Report 3007790958-2024-00045 · MDR key 20915119
Device
Product problems
- Labelling, Instructions for Use or Training Problem
- Labelling, Instructions for Use or Training Problem
Patient
NA · Male
- Burn(s)
- Burn(s)
Narrative
Description of Event or Problem
AN ATTORNEY'S OFFICE IS FILING A COURT SUMMONS NOTICE UNDER CASE REFERENCE NUMBER (B)(4) ALLEGING THAT A HEATING PAD WAS THE CAUSE OF A BURN TO IT'S CLIENTS BODY. THERE WAS NOT A REPORT OF PROPERTY DAMAGE(S) WITH THIS INCIDENT.
Additional Manufacturer Narrative
THERE IS AN INSTRUCTION THAT STATES, "BURNS CAN OCCUR REGARDLESS OF CONTROL SETTING, CHECK SKIN UNDER PAD FREQUENTLY" AND CONSUMER FAILED TO PERFORM THAT INSTRUCTION. HEATING PAD IS BUNCHED/CRUSHED WHICH SHOWS ABUSE OF THE PRODUCT AND A VIOLATION OF THE INSTRUCTIONS AND WARNINGS PROVIDED. THIS INCIDENT IS THE DIRECT RESULT OF CONSUMER MISUSE/ABUSE OF THE PRODUCT.